Associate Director Study Management, Contracts & Budget

• Contracts and budgetstrategy and oversight: Set up and lead the end-to-end operational strategy for study contracting and budgeting across assigned studies and programs aligning with CSP country requirementsbio samplingplans and funding envelopes. Serve as the single point of accountability for budget integrity and contract alignment from concept tocloseout to the endof operational strategy for study contracting and budgeting across assigned studies and programs aligning with CSP country requirements.

• FMV governance and application: Ensure countrylevel FMV benchmarks areestablished current and consistently applied across study and country budgets including sites central/specialty labs and other vendors. Document FMV methodologies justifications and deviationsin accordance withcompliance andregulations. LevelFMV benchmarks areestablished current and consistently applied across study and country budgets including sites central/specialty labs and other vendors. Document FMV methodologies justifications and deviationsin accordance withcompliance and antikickback regulations.

• Master study and country budgetsand CSA templates: Buildmaintain and own the master study and country budgetand CSAtemplates; perform scenariomodellingand sensitivity analysis based on study design changes enrolment dynamics and operational assumptions.

• BudgetandCSAdistribution to countries:Finalizeand distribute approved country budgets to SMM/country teams with clear negotiation guidance parameters and change control rules. Track implementation and provide clarification during site negotiations as needed.Maintains country study templates and adjustingchangesin due courseof the study as needed.

• CSA subject matterexpertise: Act as portfolio SME and primary POC for Clinical Study Agreements (CSAs) with SMM and Legal. Guide terms rate structures studyspecific appendices and change orders; coordinate review cycles and approvals to meet startuptimelines specificappendices andchange orders; coordinate review cycles and approvals to meet startup timelines.

• Protocol amendment impact assessment: Lead ongoing and ad hoc CSA and budget reviews triggered by protocol amendments or operational changes. Quantify impacts secure approvals adjust master and country budgets and execute contract amendments ina timelyand compliant manner.

• Documentation ownership and repository management: Ensure timely maintenance and distribution of contracting documentation including a complete version-controlled repository of signed CSAs amendments rate cards and budget approvals across the portfolio; ensure eTMF completeness and inspectionreadiness; controlledrepository of signed CSAs amendments rate cards and budget approvals across the portfolio; ensure eTMF completeness and inspection readiness.

• Partner with Finance on forecasting risk/opportunity management and governance reporting if needed.

• Cross-functional leadership and collaboration: Coordinate deliverables across Study Teams SMM Legal Procurement Finance and scientific functions; facilitate decisionmaking resolve issues and drive alignment on budget and contract priorities andtimelines; functionalleadership andcollaboration making resolve issues and drive alignment on budget and contract priorities and timelines.

• Process improvement and standardization: Establish and refine standards templates guidance and tools for budgets and CSAs; identify opportunities for automation and AIenabled solutions; lead or contribute to continuous improvement and change initiatives impacting contracting and budgetingoperations enabledsolutions; lead or contribute to continuous improvement and change initiatives impacting contracting and budgeting operations.

• Training and enablement: Provide targeted training to Study Management SMM and crossfunctional teams on budget/CSA processes FMV application and change control; collect and share lessons learned and bestpractices to functionalteams on budget/CSA processes FMV application and change control; collect and share lessons learned and best practices.

Essential Qualifications